title: Nevirapine-based antiretroviral therapy does not reduce oral contraceptive effectiveness.
abstract: OBJECTIVE
  To evaluate the effect of nevirapine-containing antiretroviral therapy (ART) on combined oral contraceptive (COC) effectiveness.
  
  
  METHODS
  Nonrandomized prospective clinical trial.
  
  
  METHODS
  We enrolled HIV-infected women aged 18-35 years in South Africa and Uganda who had regular menses, were sexually active, and had no medical contraindications to COC use. We enrolled 196 women taking nevirapine-containing ART and 206 women not yet eligible for ART as a control group. We treated all participants with low-dose COCs. Our main outcomes were ovulation and pregnancy rates. We estimated ovulation in the first two cycles using weekly serum progesterone and tested for pregnancy monthly for 24 weeks.
  
  
  RESULTS
  The median age of participants was 29 and their median CD4 cell count was 486. In the ART group, 43 of 168 (26%) ovulated in cycle 1, 30 of 163 (18%) in cycle 2, and 18 of 163 (11%) in both cycles. In the non-ART group, 26 of 168 (16%) ovulated in cycle 1, 31 of 165 (19%) in cycle 2, and 20 of 165 (12%) in both cycles. We found no significant difference in ovulation rates between groups: unadjusted odds ratio 1.36 (95% confidence interval 0.85-2.18). Pregnancy rates also did not differ: 10.0 per 100-women-years in the ART group and 10.1 per 100-women-years in the non-ART group. Self-reported COC adherence, condom use, vaginal bleeding, and adverse events were similar. Five serious adverse events were reported, all in the non-ART group.
  
  
  CONCLUSIONS
  ART use did not affect risk of ovulation or pregnancy in women taking COCs, suggesting that nevirapine-containing ART does not interfere with COC contraceptive effectiveness.
authors.affiliation: aFHI 360, Integrated Health Sciences, Research Triangle Park, North Carolina, USA bWits Reproductive Health and HIV Institute (WRHI), University of Witwatersrand, Johannesburg, South Africa cMulago Hospital, Makerere University, Kampala, Uganda dThe Aurum Institute, Parktown, Johannesburg, South Africa.
authors.forename: Kavita
authors.initials: K
authors.lastname: Nanda
authors.forename: Sinead
authors.initials: S
authors.lastname: Delany-Moretlwe
authors.forename: Karine
authors.initials: K
authors.lastname: Dubé
authors.forename: Anja
authors.initials: A
authors.lastname: Lendvay
authors.forename: Cynthia
authors.initials: C
authors.lastname: Kwok
authors.forename: Lebohang
authors.initials: L
authors.lastname: Molife
authors.forename: Sarah
authors.initials: S
authors.lastname: Nakubulwa
authors.forename: Vinodh A
authors.initials: VA
authors.lastname: Edward
authors.forename: Bernard
authors.initials: B
authors.lastname: Mpairwe
authors.forename: Florence M
authors.initials: FM
authors.lastname: Mirembe
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D003276:Contraceptives, Oral / Q000493:pharmacokinetics* / Q000494:pharmacology*; D004347:Drug Interactions; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D019829:Nevirapine / Q000008:administration & dosage*; D010060:Ovulation / Q000187:drug effects; D011247:Pregnancy; D011446:Prospective Studies; D013019:South Africa; D014454:Uganda; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D003276:Contraceptives, Oral; D019829:Nevirapine